FDA unveils plan to combat DEADLY bacterial outbreak in baby formula By Belle Carter for Grocery
The Food and Drug Administration (FDA) on November 16 laid out its plan to enhance its surveillance to prevent outbreaks of cronobacter bacteria in instant infant formula.
According to a statement released by the agency, FDA would review and update current guidelines and rules regarding the manufacturing of infant powdered formula and is considering whether to establish a dedicated group of investigators to conduct inspections of infant formula. It also said it will monitor if cronobacter infections are added to the Centers for Disease Control and Prevention‘s (CDC) list of nationally notifiable diseases, which means doctors would be required to report cases to public health officials.
FDA would also look into realigning staff across two divisions: the Center for Food Safety and Applied Nutrition and the Office of Regulatory Affairs so it can better support “regulatory oversight” of infant formula. This move seeks to review and update the Infant Formula Compliance Program to reflect current science on the said bacteria.
Furthermore, the federal agency will provide additional education and training to its regulatory staff regarding inspections of manufacturing facilities and evaluate the testing requirements of instant formula for possible improvements and enhancement of finished products.
Reports say that Minnesota is currently the only state that requires doctors to report cronobacter infections to the state health department. Because of this requirement, Minnesota was the first state to alert federal regulators to a potential problem with the powdered baby formula last year.
Early this year, the FDA inspected Abbott Nutrition plants in Sturgis, Michigan after the agency received four reports of deaths due to the consumption of powdered formula that had cronobacter in them.
Although they detected cronobacter bacteria in the plant, genetic testing couldn’t link that bacteria to sick infants. The company voluntarily recalled the infant formula. (Related: Abbott Nutrition’s infant formula was recalled after claims of bacterial contamination, infant deaths.)
“Since our voluntary recall in February, investigations conducted by the FDA, CDC and Abbott, including genetic sequencing, retained product samples and available product from the four complaints, did not find any definitive link between the company’s products and illnesses in children. No retained samples of the recalled products tested positive for cronobacter. And, in all four cases, unopened containers of formula in the infant homes tested negative for Cronobacter sakazakii,” the milk manufacturer told CNN in a written statement.
According to Epoch Times, the shutdown of Abbott’s Michigan plant exacerbated a nationwide shortage of baby formula. The plant was later restarted in July but it seems to some critics, another attack on baby’s “food” is being set with another looming shortage due to the said “bacteria.”
Cronobacter is usually harmless but can be fatal to infants and vulnerable individuals
According to the FDA website, cronobacter is a germ (bacteria) naturally found in the environment. Cronobacter can exist on almost any surface and is especially good at surviving in dry foods, like powdered infant formula, powdered milk, herbal teas and starches.
“Cronobacter is harmless for most people and infections are rare. When they occur, they can be life-threatening in infants, particularly those younger than two months old, premature, immunocompromised or of low birth weight,” the FDA website included.
Infections in very young children typically occur in the first days or weeks of life. Still, it can endanger the lives of vulnerable individuals, such as the elderly or those aged 65 years and older as well as those who have weakened immune systems, such as individuals with HIV, organ transplants or cancer.
The CDC said there are roughly two to four cases of cronobacter infections reported every year, although the agency added that the actual figure may be higher.
Symptoms of the infection in infants may start with fever, poor feeding, excessive crying and/or very low energy. Some infants may also have seizures. The FDA advises that babies with these symptoms should be taken to a medical provider as soon as possible.
The FDA reminded caregivers to be extra careful in preparing milk formulas by following the manufacturer’s instructions included on the packaging, especially for specialty metabolic formulas. Also, as infants could be exposed to infection via unclean breast pumps or bottles, they should keep your baby’s food, whether breast milk or formula, safe by carefully cleaning, sanitizing and storing bottles and breast pump parts.
“It is also important to wash your hands with soap and water, especially before preparing bottles and feeding. The CDC says that alcohol-based hand sanitizer with at least 60 percent alcohol can also be used,” the fact sheet included.